NK Cells Treatment for COVID-19
Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
1 other identifier
interventional
2
1 country
1
Brief Summary
Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 15, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 8, 2024
February 1, 2024
2.9 years
February 13, 2020
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Improvement of clinical symptoms including duration of fever
Evaluation of pneumonia improvement
Measured from day 0 through day 28
Improvement of clinical symptoms including respiratory frequency
Evaluation of pneumonia improvement
Measured from day 0 through day 28
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
Safety evaluation
Measured from day 0 through day 28
Secondary Outcomes (4)
Time of virus nucleic acid test negative
Measured from day 0 through day 28
CD4+ and CD8+ T cell count
Measured from day 0 through day 28
Rate of mortality within 28-days
Day 28
Size of lesion area by thoracic imaging
Measured from day 0 through day 28
Study Arms (2)
NK Cells Treatment Group
EXPERIMENTALConventional treatment plus NK cells. Participants will receive conventional treatment plus twice a week of NK cells (0.1-2\*10E7 NK cells/kg body weight).
Conventional Control Group
NO INTERVENTIONParticipants will only receive conventional treatment.
Interventions
twice a week of NK cells (0.1-2\*10E7 cells/kg body weight)
Eligibility Criteria
You may qualify if:
- \. Male or female, aged at 18 years-65 years old
- \. Pneumonia that is judged by chest radiograph or computed tomography
- \. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source
You may not qualify if:
- \. Pregnancy or breastfeeding
- \. Known HIV, HBV or HCV infection
- \. Patients with malignant tumor, other serious systemic diseases and psychosis
- \. Patients who are participating in other clinical trials
- \. Inability to provide informed consent or to comply with test requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453000, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 21, 2020
Study Start
February 15, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share